Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claim 1 has been amended.
Claims 1-10, 12, and 13 are pending.
Claims 11,14, and 15 have been canceled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 12, and 13 are is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sugiura et. al. (US 20190093059 A1).
Regarding claim 1, Sugiura teaches “A microfluidic cell culture device” (Title and Para [0085], cell culture device. The micro-flow path.);
“comprising a body” (Fig. 6 and Para [0194], tank main body12B and lid portion13B )
“wherein said body comprises a fluid system” (Figs. 5-7)
“comprising a first fluid chamber” (Para [0062], first culture liquid storage chamber 1);
”a second fluid chamber” (Para [0062], second culture liquid storage chamber 2);
“a cell culture chamber” (Para [0062], culture liquid main chamber 3);
“and a flow channel” (Para [0062], a culture liquid introduction flow path 5);
“for allowing a flow of fluid from said first chamber, via said cell culture chamber, towards said second chamber upon coupling of a pressure pump system” (Para [0102], pressurizing pump 14)
“to said fluid system;” [0109] Due to the pressure increase in the first culture liquid storage chamber 1, the culture liquid C1 in the first culture liquid storage chamber 1 is introduced into the circulation space 3a of the culture liquid main chamber 3 through the culture liquid introduction flow path 5. The culture liquid C1 in the circulation space 3a is introduced into the second culture liquid storage chamber 2 through the culture liquid lead-out flow path 6.);
“wherein the fluid system further comprises a return channel” (Para [0062], a communication flow path 7.);
“formed in said body allowing a flow of fluid from said second chamber to said first chamber.” (Para [0111], using the pressurizing pump 14 to pressurize the inside of each chamber, the culture liquid C1 in the second culture liquid storage chamber 2 is introduced into the first culture liquid storage chamber 1 through the communication flow path 7 due to the pressure increase in the second culture liquid storage chamber 2.).
“wherein the cell culture chamber in the body is open towards a surface of the body for receiving a cell culture insert, wherein the cell culture insert and the cell culture chamber in the body together form a substantially closed area.” (Para [0064], [0037], [0137] and [0078], In the storage tank 11, it is possible to form a sampling hole (not shown in the drawings) communicating with the outer surface side space 3b. Accordingly, it is possible to collect a liquid in the outer surface side space 3b through the sampling hole. The culture liquid main chamber 3 is a hollow portion formed in the storage tank 11. A lid portion that airtightly closes openings of the culture liquid main chamber, the first culture liquid storage chamber, and the second culture liquid storage chamber in an openable manner. The lid portion 13 is capable of airtightly closing the opening of the tank main body 12 in an openable manner. Specifically, the lid portion 13 is capable of airtightly closing upper openings 1b and 2b of the first culture liquid storage chamber 1 and the second culture liquid storage chamber 2. An example of a structure in which the lid portion 13 airtightly closes the upper openings 1b and 2b includes a structure in which the lid portion 13 abuts on the upper surface of the tank main body 12 with a packing 15 interposed therebetween, and the packing 15 is provided so as to surround each of the upper openings 1b and 2b. In FIG. 1, the lid portion 13 is shown separately from the tank main body 12. An example of a structure in which the lid portion 13B airtightly closes the upper openings 1b, 2b, 21b, and 22b includes a structure in which the lid portion 13 abuts on the upper surface of the tank main body 12B with a packing 15 interposed therebetween, and the packing 15 is provided so as to surround each of the upper openings 1b, 2b, 21b, and 22b.).
Regarding claim 2, Sugiura teaches all of claim 1 as above in addition to “further comprising a fluid directing mechanism arranged for providing a substantially unidirectional flow in the flow channel.” (Para [0032], The cell culture device according to (6), in which the backflow prevention mechanism is a check valve which allows the flow of the culture liquid in a direction from the culture liquid lead-out flow path to the second culture liquid storage chamber and prevents flow in an opposite direction thereof.). Therefore the flow is in the direction from culture liquid lead-out flow path to the second culture liquid storage chamber which is where the flow channel is located in that flow direction.
Regarding claim 3, Sugiura teaches all of claim 2 as above in addition to “wherein the fluid directing mechanism comprises at least one valve provided in at least one of the return channel and the flow channel.” (Fig. 4, Paras [0080] and [0081], A Laplace valve 31 which allows flow of a liquid from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 (flow channel) and prevents inflow of gas from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 is provided at one end of the culture liquid introduction flow path 5 in the first culture liquid storage chamber 1. A check valve 32 which allows flow of a liquid in a direction from the communication flow path 7 (return channel) to the first culture liquid storage chamber 1 and prevents flow in an opposite direction thereof is provided at the other end of the communication flow path 7 in the first culture liquid storage chamber 1.
Regarding claim 4, Sugiura teaches all of claim 3 as above in addition to, “wherein the fluid directing mechanism comprises at least one pneumatic valve.” (Paras [0080] and [0102], A Laplace valve 31 which allows flow of a liquid from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 and prevents inflow of gas from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 is provided at one end of the culture liquid introduction flow path 5 in the first culture liquid storage chamber 1. The pressurizing pump 14 is, for example, a compressor.) Therefore the control of gas by preventing inflow of gas from the first culture liquid storage chamber teaches to the valve being pneumatic.
Regarding claim 5, Sugiura teaches all of claim 3 as above in addition to “wherein the fluid directing mechanism comprises at least one one-way valve.” (Para [0032], The cell culture device according to (6), in which the backflow prevention mechanism is a check valve which allows the flow of the culture liquid in a direction from the culture liquid lead-out flow path to the second culture liquid storage chamber and prevents flow in an opposite direction thereof.).
Regarding claim 6, Sugiura teaches all of claim 5 as above in addition to “ wherein the one-way valve comprises a microfluidic passive check valve.” (Para [0085], Under such a condition, the micro-flow path can be treated as a passive air inflow prevention mechanism.).
Regarding claim 7, Sugiura teaches all of claim 3 as above in addition to “wherein the valve is arranged in a upstream region of the respective channel.” (Fig. 4, Paras [0080], A Laplace valve 31 which allows flow of a liquid from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 (flow channel) and prevents inflow of gas from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 is provided at one end of the culture liquid introduction flow path 5 in the first culture liquid storage chamber 1.) Therefore the valve is upstream the flow channel.
Regarding claim 8, Sugiura teaches all of claim 3 as above in addition to “wherein both the flow channel and the return channel are provided with a valve.” (Fig. 4, Paras [0080] and [0081], A Laplace valve 31 which allows flow of a liquid from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 (flow channel) and prevents inflow of gas from the first culture liquid storage chamber 1 to the culture liquid introduction flow path 5 is provided at one end of the culture liquid introduction flow path 5 in the first culture liquid storage chamber 1. A check valve 32 which allows flow of a liquid in a direction from the communication flow path 7 (return channel) to the first culture liquid storage chamber 1 and prevents flow in an opposite direction thereof is provided at the other end of the communication flow path 7 in the first culture liquid storage chamber 1.).
Regarding claim 9, Sugiura teaches all of claim 1 as above in addition to “wherein at least one of the first and the second chambers are arranged to be coupled to a pump system for pressurizing at least one of the first and the second chambers.” (Para [0108], The pressurizing pump 14 is operated to pressurize the inside of the first culture liquid storage chamber 1 by supplying gas (for example, air) to the first culture liquid storage chamber 1 through the vent hole 1h.).
Regarding claim 10, Sugiura teaches all of claim 9 as above in addition to, “wherein the pump system is a pneumatic pressurization system.” (Para, [0102] The pressurizing pump 14 is, for example, a compressor.)
Regarding claim 12, Sugiura teaches all of claim 1 as above in addition to “comprising a plurality of separated fluid systems.” (Para [0116], As shown in FIG. 3, a storage tank 11A in the cell culture device 10A has a plurality of cell culture units 9.).
Regarding claim 13, Sugiura teaches all of claim 1 as above in addition to “wherein the body comprises a plurality of stacked layers” (Fig. 7); “wherein the fluid system is formed by channels and openings formed in the plurality of layers.” (Para [0183] The wall portion 46 has a plurality of through-hole portions 50 penetratingly formed in a thickness direction. The first culture liquid storage chamber 1, the second culture liquid storage chamber 2, the culture liquid main chamber 3, the first liquid storage chamber 21, and the second liquid storage chamber 22 are spaces partitioned by the through-hole portions 50 and the bottom plate 45. Each of the shapes in the plan views of the chambers 1, 2, 3, 21, 22 is oval.).
Response to Arguments
Applicant argues that Sugiura fails to teach a cell culture chamber that is open for receiving a cell culture insert. Applicant further argues that the cell culture insert is a distinct component that is placed within the chamber to form a closed area.
In response, the examiner respectfully disagrees. The limitation recites “the cell culture chamber in the body is open towards a surface of the body for receiving a cell culture insert”. Under broadest reasonable interpretation, the limitation merely requires the cell culture chamber to be designed to receive an insert (or plug). The “cell culture insert” is not positively claimed such that it is required by the claimed invention. In this case, since Sugiura discloses cell culture chambers (e.g., chambers 1, 2) with openings (upper openings 1b, 2b), this meets the limitation since Sugiura discloses every necessary feature of cell culture chambers (e.g., chambers 1, 2) required for “receiving a cell culture insert”. See MPEP 2114.
Further, the recitation “wherein the cell culture insert and the cell culture chamber in the body together form a substantially closed area” merely refers to an expected result of arranging an insert in the opening of the cell culture chamber. In this case, Sugiura also teaches a lid portion (13) with the packing that forms a closed area which corresponds to the cap described in applicant’s specification (Spec., Pg. 6, lines 15-18, A cap may be used to compress the insert on the microfluidic cell culture device, keeping the fluidic layer sealed, for instance using direct plastic-on-plastic contact or a gasket”).
The examiner suggests language such as “wherein the microfluidic cell culture device further comprises a cell culture insert, wherein the cell culture insert is arranged on the cell culture chamber to form a substantially closed area” to clarify that the cell culture insert is positively recited and part of the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights